The pharmacokinetic (PK) profile involves the study of the time course of drug absorption, distribution, metabolism, and excretion. For large molecule drugs, such as monoclonal antibodies (mAbs), bispecifics, and antibody-drug conjugates (ADCs), understanding PK properties is far more complex than for small molecules due to structural heterogeneity and target-mediated drug disposition (TMDD). BOC Sciences provides comprehensive biologics & biosimilar PK analysis services to support early-stage drug discovery and lead optimization. By utilizing high-sensitivity Ligand Binding Assays (LBA) and hybrid LC-MS/MS platforms, we accurately determine serum concentrations, half-life, and bioavailability. Our data empowers researchers to optimize molecular design, select the most promising candidates, and establish scientific evidence for dosing strategies in pre-clinical development.
We provide precise quantification of drug concentrations using diverse platforms to match sensitivity and throughput needs.
Our comprehensive immunogenicity testing characterizes anti-drug antibodies to evaluate safety and efficacy risks.
We quantify biological indicators to demonstrate proof of mechanism and monitor disease progression.
We measure the binding of therapeutics to cellular targets to define the PK/PD relationship.
We assess the functional potency of biologics through cell-based and enzymatic readouts.
We characterize in vivo structural changes to understand catabolism and stability of complex biologics.
BOC Sciences delivers high-quality PK data to bridge the gap between molecular design and pharmacological effect.
BOC Sciences specializes in the bioanalysis of complex biological modalities, tailoring extraction and detection strategies to the unique properties of each molecule type.
Submit your molecule details today. Our experts will design a bioanalytical strategy to fully characterize the disposition of your biologic or biosimilar.
We define the PK study scope based on your drug type (Innovator or Biosimilar). Our scientists recommend appropriate assay platforms (LBA or LC-MS) and sampling schedules.
We develop a new method or transfer an existing one, optimizing reagents and conditions to ensure specificity, linearity, and recovery in the target biological matrix.
Biological samples are processed and analyzed. We perform rigorous checks to monitor assay performance, including standard curves and quality control (QC) samples.
We calculate key PK parameters (Half-life, Cmax, AUC, Clearance) using industry-standard software and deliver a detailed report supporting your internal R&D decisions.
In the hit-to-lead stage, rapid turnover is essential. Our high-throughput PK screening allows for the parallel evaluation of multiple candidates. We provide "snapshot" PK data to help clients quickly rank clones or variants based on their stability and circulation time, filtering out candidates with poor developability early on.
For candidates undergoing Fc-engineering or half-life extension modifications, precise PK profiling is critical. We analyze how structural changes impact clearance and distribution, providing feedback to protein engineers to refine the molecule for optimal therapeutic windows.
We provide analytical solutions to prove "high similarity" in PK fingerprints. By running side-by-side comparisons of the biosimilar and the originator product, we generate data on overlaying concentration-time curves, helping to de-risk the program before costly downstream development.
Changes in formulation (buffer, pH, excipients) can alter the absorption and bioavailability of biologics, especially for subcutaneous delivery. We support formulation development teams by assessing the in vivo PK impact of different formulation prototypes to ensure consistent drug delivery.
From simple peptides to complex multi-specific antibodies, BOC Sciences provides the bioanalytical expertise needed to decode pharmacokinetics. Let us help you optimize your dosing strategies with high-confidence data.
We are not limited to a single technology. By offering ELISA, MSD, and LC-MS/MS, we match the method to the molecule, ensuring optimal sensitivity and selectivity for your specific biological entity.
Our team has extensive experience handling difficult molecules like ADCs (measuring conjugated vs. total antibody vs. free payload) and bispecifics, addressing challenges that standard assays cannot resolve.
For screening stages, we utilize automated liquid handling and efficient assay designs to process large sample numbers quickly, reducing the turnaround time for your candidate selection decisions.
We don't just deliver raw numbers. Our scientists assist in interpreting non-linear PK profiles, TMDD effects, and the potential impact of anti-drug antibodies (ADA) on drug clearance.
Client Needs: A biotech client developed a novel bispecific antibody (BsAb) targeting two distinct tumor antigens. They needed to understand the pharmacokinetic stability of the intact molecule versus potential fragments in the serum to guide lead optimization.
Challenges: Standard ELISA reagents could not differentiate between the intact BsAb and single-arm fragments that might result from in vivo instability. The lack of specific detection reagents for the novel construct made quantification difficult, leading to ambiguous half-life data.
Solution: BOC Sciences engineered a robust orthogonal bioanalytical strategy. We designed a specialized Bridging ELISA (Capture: Anti-Target A / Detection: Anti-Target B) that exclusively generates a signal when the bispecific structure is intact. This was paired with a Total IgG assay to monitor overall exposure. We rigorously validated the method for specificity, ensuring no cross-reactivity with homodimer byproducts or circulating targets, providing a definitive assessment of structural integrity.
Outcome: By comparing the results of the two assays, we successfully quantified the intact molecule and assessed structural stability in circulation. The data allowed the client to modify the hinge region sequence, significantly improving the in vivo stability of the final candidate.
Client Needs: A developer required a comparative PK study for a biosimilar candidate of a blockbuster monoclonal antibody to confirm similarity in absorption and elimination phases prior to scaling up production.
Challenges: The originator drug exhibited non-linear PK due to target-mediated clearance at lower doses. The client needed an assay with a wide dynamic range and high precision to capture the full profile and ensure the biosimilar matched the reference product's non-linear behavior.
Solution: We executed a scientifically rigorous head-to-head parallelism assessment using a high-sensitivity ECL platform with a wide dynamic range (4-log). To minimize analytical bias, we employed a blinded analysis design and utilized a single lot of critical reagents for both the biosimilar and reference product. This approach eliminated inter-assay variability, ensuring that the generated concentration data was purely reflective of the molecules' pharmacokinetic performance.
Outcome: The results demonstrated superimposable concentration-time curves for both the biosimilar and the reference product. The calculated PK parameters (AUC, Cmax, T1/2) fell well within the acceptance criteria for similarity, giving the client confidence to proceed.
Client Needs: An R&D team working on an ADC needed to evaluate linker stability by measuring three distinct analytes: total antibody, conjugated antibody, and free toxic payload.
Challenges: Measuring free payload is challenging due to its extremely low concentration and potential interference from the protein component. Furthermore, the "drug-to-antibody ratio" (DAR) changes in vivo, complicating the interpretation of "active" drug levels.
Solution: We deployed an integrated Hybrid LBA/LC-MS/MS workflow for comprehensive coverage. For the large molecule component, we utilized an anti-idiotype LBA to quantify Total Antibody and Conjugated Antibody (measuring intact linker-drug). Simultaneously, we developed an ultra-sensitive LC-MS/MS method with optimized protein precipitation to quantify trace levels of the free payload. This multi-analyte approach provided a complete kinetic profile of linker stability and deconjugation.
Outcome: The comprehensive dataset revealed premature linker cleavage in the initial candidate. This insight prompted a redesign of the linker chemistry, leading to a second-generation ADC with improved safety and PK profiles.
Designing biologics PK studies requires consideration of molecular characteristics, dose levels, and administration routes affecting systemic exposure and half-life. BOC Sciences offers customized PK study plans for antibodies, fusion proteins, and recombinant proteins, combining multi-point sampling and high-sensitivity detection to generate reliable pharmacokinetic data supporting development decisions.
PK analysis typically uses high-sensitivity detection methods such as ELISA, LC-MS/MS, or electrochemiluminescence (ECL) to accurately quantify biologics. BOC Sciences provides multi-platform analysis capabilities, selecting the most suitable method based on molecular properties, delivering high-throughput and precise PK data to support pharmacokinetic evaluation.
Assessing biosimilar PK similarity requires comparing reference products and candidates in terms of systemic exposure, half-life, and clearance. BOC Sciences provides comprehensive PK analysis services, including quantitative detection and data modeling, enabling precise evaluation of pharmacokinetic similarity to support biosimilar development.
Common PK models include nonlinear mixed-effects (NLME) models, non-compartmental, and compartmental models to analyze absorption, distribution, and clearance characteristics. BOC Sciences’ experienced modeling team performs accurate modeling and parameter estimation based on experimental data, delivering interpretable PK analysis reports for clients.
Optimizing antibody dosing strategies requires integrating pharmacokinetic characteristics, half-life, and exposure levels, adjusting dosing intervals to achieve optimal efficacy. BOC Sciences uses in vivo PK analysis and modeling simulations to provide data-driven dosing optimization recommendations, supporting rational molecule design and combination development decisions.
We struggled with matrix interference for our fusion protein project. BOC Sciences developed a custom method that completely resolved the background issues. Their PK data was clean, reproducible, and delivered ahead of schedule.
— Dr. Arthur, Senior Scientist, Biologics Discovery
The team understood the complexity of our bispecific antibody immediately. Their dual-assay approach gave us the confidence that our molecule was stable in vivo. A true partner in our R&D efforts.
— Dr. Lucas, Director of Pharmacology, Biotech Startup
For our biosimilar comparison, precision was everything. BOC Sciences provided robust data with excellent statistical similarity analysis. Their reports are comprehensive and scientifically sound.
— Dr. James, VP of R&D, Biosimilar Developer
We needed a quick turnaround on a PK screen for five variants. BOC Sciences accommodated our timeline without sacrificing quality. The data helped us select our lead candidate efficiently.
— Dr. Thomas, Project Manager, Pharma Company
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